In recent years, we have entered an exciting era in breakthroughs in product development for nutritional supplements, and these innovations aren’t just apparent in the final products. Starting at the idea phase and including every step from marketing strategies, to ingredient development, to scientific testing methods, the nutritional supplements industry is evolving quickly. And the upcoming Natural Products Expo West is a great place to explore all the fascinating changes we can expect in the coming years.
Transparency in Marketing
One important trend is that nutritional/food companies have made sincere efforts recently to place transparency at the foundation of their marketing strategies. There have been industry initiatives to transform this aspect of their business practices, such as the Supplemental Safety and Compliance Initiative, which aims “to provide a harmonized benchmark to recognize various safety standards throughout the entire dietary supplement supply chain.” In addition, agencies like CRN and its Supplement OWL (Online Wellness Library) are advocating for transparency in the industry by creating and maintaining an authoritative database with access to extensive label information on supplemental products.
There has also been a great deal of innovation in delivery techniques and the industry has seen the rise of customization and personalization in dietary supplements. From vegetarian softgels to bilayer and even trilayer manufacturing, there’s much to be interested in when it comes to the next few years of development. There’s also significant evolution in the capsule space, including the capsule within the capsule, which is ideal for combination products with diﬀerent release proﬁles or for dual release of a single ingredient.
Science Behind the Wheel
The NHP Research Alliance under the direction of Dr. Steven Newmaster at the University of Guelph, Canada, is interested an extensive Biological Reference Material Library (BRM) that can be accessed by industry partners, and regulators with the goal of setting clear standards and offering affordable DNA-based tools. This innovative approach to testing supplements is being embraced by major suppliers in the US, China, and UK. One area using this model is probiotics, whose roll is moving beyond just digestive health, with evidence that suggests an important role in health issues including heart and brain health, weight management, and immune support, and blood sugar control.
Deerland at Expo West 2019
Innovations in food science, supplements, and other products are no stranger to Natural Products Expo West. The 39th annual Natural Products Expo West is the world’s largest natural, organic and healthy products event. The 2019 event will be held in Anaheim, California, from March 6 though March 8. We hope you’ll visit Deerland Probiotics and Enzymes at booth 4571. Stop by and talk with us about what’s new and exciting in enzymes and probiotics. Meet with our product development experts and let them know what the formulation needs are for you and your brand.
With a team of industry experts working in a state-of-the-art lab, Deerland is positioned to serve customers from the initial stages of product conceptualization, through the design phase, ﬁnal formulation and contract manufacturing. From concept to commercialization, we add value at every step.
Click here to learn more about the science-driven innovation at Deerland!
Consumer demand is driving production for probiotic solutions as new technologies and more information become available regarding the importance of gut health. Previously, the achilles heel of the supplement industry has often been the lack of scientific evidence to support claims.
Initiatives such as the Human Microbiome Project, a worldwide initiative that’s attempting to map out the entire microbiome, has helped to increase education and understanding of the microbiome’s impact on health.
Listen in to learn how the current marketplace for supplements is changing, how consumer demand impacts this, and why clinical studies are the most difficult-to-surpass but most necessary barrier to entry.
The US Food and Drug Administration has issued a draft guidance on labeling of live microbial ingredients (probiotics) as colony forming units (CFUs) in addition to weight, as is currently specified in the regulations.
Read more at nutraingredients-usa.com
A study demonstrating a new way to test for the presence of gluten in enzyme supplements has been published in the Journal of Nutrition & Food Sciences. The study was motivated by the growing demand for gluten free products and the need for accurate testing methodologies for products claiming to meet the “gluten free” standard of less than 20 ppm, according to co-author Dr. John Deaton, vice president of science and technology for Deerland Probiotics & Enzymes.
The industry’s leading manufacturer and supplier of the enzyme nattokinase has officially received a Natural Product Number for NSK-SD® from Health Canada, allowing for the sale of finished products containing NSK-SD nattokinase.
Under the NPN, finished products containing the NSK-SD nattokinase enzyme may make the health claim “helps support cardiovascular system health.” The product is also the only EFSA-approved nattokinase on the market.
What is Nattokinase?
NSK-SD® nattokinase is a potent fibrinolytic enzyme produced from the fermentation of boiled soybeans by B. subtilis. This process results in the traditional Japanese food, Natto, from where the enzyme gets its name.
NSK-SD® nattokinase may help to normalize blood viscosity and pressure by degrading circulating fibrin. According to the manufacturer, NSK-SD® has been researched for more than 25 years, with results suggesting numerous circulatory benefits.
2017 was an exciting year for Deerland Probiotics & Enzymes. Check out this infographic for some of the highlights. We’re looking forward to what’s to come!
Click the image below to enlarge.
Taking A Bite Out of FSMA Compliance: How Upcoming Regulations Will Affect Food and Supplement Manufacturers
On January 4th 2011, the former President of the United States, Barack Obama, signed into law one of the most innovative and comprehensive revisions to food safety in almost eighty years. The Food Safety and Modernization Act (FSMA) represents a floor to ceiling remodel of how the FDA will approach and regulate food safety practices. This new set of regulations has already started to go into effect, and implementation will continue through 2019.
Coupled with the need to protect America’s food source from potential bioterrorism, part of the reason for the introduction of FSMA was the spike in number and severity of food-borne illness outbreaks in the early 2000s. For example, in 2006 contaminated organic spinach let to the death of 3 people and sickened more than 200 others. In 2007, contaminated peanut butter sickened more than 600 people; and, in 2008, imported peppers sickened more than 1400 people. In 2009, what could be the most horrific incident in recent history occurred when the Peanut Corporation of America shipped product that tested positive for salmonella, but passed a re-test. They performed no investigation and did not clean the facility after the results were reported. This contamination killed 8 people and sickened more than 500 others in 43 different states. The FDA estimates that nearly 1 in 6 people in the USA will get sick this year from foodborne diseases.
The changes posed in the new laws will affect not only traditional food companies, but supplement manufacturers as well. Are you and your team prepared for the upcoming changes?
There are several key ways that the FSMA will affect companies and further empower the FDA.
- The idea of proactive rather than reactive contamination efforts.
The FSMA grants the FDA the ability to conduct more thorough prevention-based efforts., requiring companies to put proactive, risked-based, prevention plans in place. For every manufactured product, the company must evaluate hazards, develop a written hazard analysis, validate and monitor preventative controls, and take necessary corrective actions.
- Mandatory recall authority.
For the first time, the FDA will be able to mandate companies recall products deemed unsafe. This provision will give the government real “claws” to tackle with potentially serious pathogen outbreaks.
- Tougher importation food safety standards.
All importers now have a stated responsibility to ensure that foreign suppliers have adequate food controls in place. There are several other certifications that will impact quality control for high risk foods. If these requirements are not met, the FDA can block entry of these consumables.
- Increased ability to conduct inspections and assure compliance.
To help fulfill this portion of FSMA, the FDA is looking to hire hundreds of additional personnel. These staff members will have an enhanced ability to check-up on manufacturers and sign off on compliance measures.
- Increased cooperation between inter-governmental departments.
Washington is pushing for better collaboration between its governing bodies. This means that food safety issues may now be handled and shared between previously separate entities.
In addition to these five changes, the FMSA will also call for food safety plans, food defense plans, biennial registration with the FDA, and a reportable food registry.
Supplement manufacturers must be prepared for these coming changes. Compliance with new FSMA standards is already happening at companies like Deerland Probiotics & Enzymes and Probiotics. Learn more about what you need to do comply here.
The industry’s leading manufacturer and supplier of nattokinase has announced the publication and noted approval of NSK-SD® nattokinase on the Union market as a novel food ingredient under the Article 1(2) of Regulation (EC) No 258/97. NSK-SD has been approved in all 28 EU member states and was featured in the Office Journal of the European Union. As expected, EFSA also noted that NSK-SD exhibits in vitro fibrinolytic activity and in vitro thrombolytic activity in animals when administered parenterally.
What is Nattokinase?
NSK SD® nattokinase is a potent fibrinolytic enzyme produced from the fermentation of boiled soybeans by B. subtilis. This process results in the traditional Japanese food, Natto, from where the enzyme gets its name.
NSK SD® nattokinase may help to normalize blood viscosity and pressure by degrading circulating fibrin. According to the manufacturer, NSK-SD® has been researched for more than 25 years, with results suggesting numerous circulatory benefits.
Here’s a link to the European law and all documentation associated with this approval of fermented soybean extract:
Washington, D.C., January 9, 2017—The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, and the International Probiotics Association (IPA), an international membership organization of probiotic companies, today announce the development of scientifically-based best practices guidelines for the labeling, storing, and stability testing of dietary supplements and functional foods containing probiotics. As probiotics are quickly gaining popularity, the guidelines are designed to ensure probiotic manufacturers can consistently create high-quality products that consumers can be confident in.
If current trends hold true, probiotic dietary supplements will be the fastest-growing supplement category in North America in 2016–2021, according to a presentation by market researcher Euromonitor at October’s SupplySide West trade show. During this time frame, North America’s probiotic supplement growth (55%) will also outpace the rest of the world’s (38%).
Read more at nutritionaloutlook.com.
FDA is expected to issue a revised draft document governing new dietary ingredient (NDI) notifications to the agency.
Industry sources described release of the document as “imminent” and said it could be unveiled in the coming weeks in response to criticisms that the July 2011 guidance poses undue burdens to companies and is contrary to the 1994 Dietary Supplement Health and Education Act (DSHEA).
Read more at naturalproductsinsider.com.